Chronic Subdural Hematoma - Reduction of Recurrence by Treatment With Angiotensin Converting Enzyme Inhibitors
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 47
- 主要终点
- Size of Chronic Subdural Hematoma (CSDH)
研究概览
简要总结
The project aims at investigating if treatment with the Angiotensin Converting Enzyme inhibitor Coversyl (perindopril) for 3 months after surgery for chronic subdural hematoma will decrease the risc of recurrence.
详细描述
Previous studies have indicated that treatment with ACE inhibitors can reduce the risk of recurrence of CSDH after surgical evacuation. This randomized clinical trial was designed to investigate this
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with chronic subdural hematoma that needs surgical evacuation
- •Age > 18 year
排除标准
- •Lack of compliance
- •Kidney artery stenosis
- •Stenosis of the aorta
- •Severely decreased kidney function
- •Allergy or intolerance/contraindications toward ACE inhibitors
- •Already in ACE inhibitor treatment
- •Coagulopathies
- •Malignant disorders
- •Fertile women
- •Other neurological disorders
- •Treatment with pharmaceuticals contraindicating treatment with ACE inhibitors
研究组 & 干预措施
ACE inhibitor
patients randomized to this arm will be treated with ACE inhibitors after surgery
干预措施: Perindopril (Drug)
Placebo
patients randomized to this arm will be treated with placebo after surgery
干预措施: Placebo (Drug)
结局指标
主要结局
Size of Chronic Subdural Hematoma (CSDH)
时间窗: 3 months
Volume of CSDH remnant three months after evacuation measure using xyz/2 on CT scans
次要结局
- Composition of Chronic Subdural Hematoma Fluid(years)
研究者
Frantz Rom Poulsen
MD PhD
Odense University Hospital